Indianapolis, INNCT06825559Now EnrollingIRB Ready

Cholestatic Liver Disease Clinical Trial in Indianapolis, IN

Access cutting-edge cholestatic liver disease treatment through this phase 1 clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by Zydus Therapeutics Inc.

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Expert Care in Indianapolis

Access cholestatic liver disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related cholestatic liver disease treatment provided free

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Check if you qualify for this cholestatic liver disease clinical trial in Indianapolis, IN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Cholestatic Liver Disease Study in Indianapolis

Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease

Sponsor: Zydus Therapeutics Inc.

Who Can Participate

Inclusion Criteria

Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
Ability to swallow and retain oral medication.
Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to 9. If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening: Alkaline Phosphatase \> upper limit of normal Alanine aminotransferase/Aspartate aminotransferase value ≤ 10 × upper limit of normal Absolute neutrophil count ≥ 750/mm3 Platelets ≥ 25,000/mm3 Hemoglobin ≥ 8 g/dL α-fetoprotein \<50 ng/mL or 50-80 ng/mL with negative imaging study (Ultrasound \[US\], computed tomography scan \[CT\], Magnetic Resonance Imaging \[MRI\]). Imaging study that excluded presence of liver cancer (US in the preceding 6 months and CT or MRI in the preceding 1 year)
Must provide written informed consent and agree to comply with the trial protocol.

Exclusion Criteria

Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
Any major surgery within 3 months of screening.
Donation of blood or blood products within 3 months of screening.
Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
Estimated glomerular filtration rate (\<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
Any individual with poor peripheral venous access.
Receipt of blood products within 1 month of check in.
Human immunodeficiency virus type 1 antibody positive at screening.
Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the investigator and subject's medical records.
Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.
Subjects having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.
Pregnancy-related exclusions, including: Pregnant/lactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT06825559) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cholestatic Liver Disease Treatment Options in Indianapolis, IN

If you're searching for cholestatic liver disease treatment options in Indianapolis, IN, this clinical trial (NCT06825559) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced cholestatic liver disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cholestatic liver disease clinical trials near you to find additional studies recruiting in your area.

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